Thursday January 13, 7:00 am Eastern Time
Company Press Release
SOURCE: Cephalon, Inc.
SAN FRANCISCO, Jan. 13 /PRNewswire/ -- Cephalon, Inc. (Nasdaq: CEPH - news) president and chief executive officer, Frank Baldino, Jr., Ph.D., reported positive new findings from recently completed clinical studies with the company's flagship product, PROVIGIL® (modafinil) Tablets [C-IV]. The company currently markets PROVIGIL in several countries, including the United States, for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy.
In remarks delivered to investors attending Hambrecht & Quist's 18th Annual Healthcare Conference in San Francisco, Dr. Baldino reported that data from a 72-patient, placebo-controlled multiple sclerosis (MS) fatigue study showed that 200 mg of PROVIGIL reduced fatigue in patients. As measured by several validated fatigue rating scales, this reduction was statistically significant. Approximately 80 percent of the 250,000-350,000 people with MS experience fatigue; in many patients, fatigue may be the most prominent and disabling symptom. Cephalon may conduct additional studies of PROVIGIL in patients with MS fatigue later this year.
In another trial, data from a placebo-controlled simulated shift work study in 16 individuals indicated that 200 mg of PROVIGIL promoted alertness and improved performance as measured by several validated scales. These data were statistically significant. Because shift workers typically work during the night, they often experience a disruption in their sleep/wake cycle, which can lead to impaired performance. Sleep/wake cycle disruptions interfere with the body's internal biological clock that regulates several important cellular processes, including sleep. According to the U.S Department of Labor, approximately fourteen million Americans are shift workers.
In these studies, the most frequently reported side effects potentially attributable to the drug were nervousness, nausea, dry mouth, headache, and diarrhea, which were consistent with the side effects observed in the company's narcolepsy clinical trials.
Clinical investigators are expected to report results of these studies at appropriate medical meetings later this year. Cephalon is currently conducting a large-scale study of PROVIGIL in adults with attention deficit/hyperactivity disorder (ADHD) and, if successful, will begin a clinical program to test PROVIGIL in children with ADHD. In addition, the company is conducting clinical studies with PROVIGIL in patients with EDS resulting from sleep disorders or fatigue associated with certain neurological diseases.
PROVIGIL is approved by the U.S. Food and Drug Administration to improve wakefulness in patients with EDS associated with narcolepsy. The most common side effects associated with PROVIGIL in treating EDS associated with narcolepsy include nausea, infection, nervousness, anxiety and insomnia.
Cephalon, Inc., headquartered in West Chester, PA, is an international biopharmaceutical company dedicated to the discovery, development and marketing of products to treat sleep disorders, neurological disorders, and cancer.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings projections, and other statements regarding matters that are not historical facts.
You may identify some of these forward-looking statements by the use
of words in the statements such as "anticipate,'' "estimate,'' "expect,''
"project,'' "intend,'' "plan,'' "believe'' or other words and terms of
similar meaning. Cephalon's performance and financial results could differ
materially from those reflected in these forward-looking statements due
to general financial, economic, regulatory and political conditions affecting
the biotechnology and pharmaceutical industries as well as more specific
risks and uncertainties such as those set forth below and in its reports
on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange
Commission. Given these risks and uncertainties, any or all of these forward-looking
statements may prove to be incorrect. Therefore, you are cautioned not
to place too much reliance on any such factors or forward-looking statements.
Furthermore, Cephalon does not intend (and it is not obligated) to update
publicly any forward-looking statements, whether as a result of new information,
future events or otherwise. This discussion is permitted by the Private
Securities Litigation Reform Act of 1995.
SOURCE: Cephalon, Inc.